For many years, experts in medicine and academic institutions have searched for breakthroughs to effectively deliver medicine in lower dosages and with less toxicity to the body that can also pass through the protective layers of the blood-brain (BBB) and blood retinal-barriers (BRB). Many drugs are shelved due to toxicity and/or for neurological or ocular diseases, their inability to pass through these barriers.
Dendrimers are nano-sized, man-made compounds consisting of a central core surrounded by branches with terminal functional groups at the end of each branch. The carefully tailored architecture of these branches can be modified to alter the physicochemical or biological properties of the dendrimer.
After 20 years of research at the Johns Hopkins University School of Medicine, Ashvattha Therapeutics has developed and patented a new category of molecules called hydroxyl dendrimers for targeted drug delivery. Based in Baltimore, MD with corporate headquarters in Redwood City, CA, Ashvattha is able to conjugate existing medications with their hydroxyl dendrimer and create an all-together new drug molecule, resulting in a significant overhaul in the qualities of the existing drug. This new drug maintains its therapeutic effects while taking on the unique properties of Ashvattha’s dendrimers, which allows the medicine to be transported directly to cells in need of treatment while avoiding delivering the medication to healthy cells (which leads to off-target toxicity). Additionally, the dendrimer facilitates the transportation of this medication across typically prohibitive barriers, like the blood-brain barrier and the blood-retinal barrier. All in all, Ashvattha’s ability to conjugate drugs with their dendrimer can lead simple over-the-counter medications to have profound effects. Take the example of N-acetyl cysteine, an easily accessible cough medicine which when coupled with Ashvattha’s dendrimer can potentially be used to treat COVID-19 and neurodegenerative disorders. Notably, Ashvattha’s dendrimer will also likely lower the cost of treatment, as hydroxyl dendrimers are cheap to produce and will decrease the amount of medication needed by increasing the efficiency of drug delivery.
Ashvattha’s patented hydroxyl dendrimer has a unique set of abilities: it can pass through the BBB and BRB, target specific cells, and remain in them for up to one month. These characteristics allow the hydroxyl dendrimer to deliver medication only to targeted unhealthy cells, reducing frequency and improving the precision of dosages as well as eliminating off-target toxicity caused when drug molecules bind to healthy cells.
Notably, Ashvattha is not discovering new drugs but rather conjugating the hydroxyl dendrimer with existing medications, creating new compounds with their dendrimer’s unique delivery characteristics to more effectively treat many diseases. Ashvattha is currently developing various dendrimer-drug combinations for ophthalmology, imaging, macular degeneration and non-alcoholic steatohepatitis (NASH). For more information on the progress of specific combinations you can read Ashvattha’s newsletter here.
Ashvattha’s IP is protected with over 25 patents of the use of their hydroxyl dendrimer and has 50 pending patents worldwide.
Ashvattha on inflammation including COVID-19 symptoms
While inflammation is a natural immune response, in excess it can harm healthy cells leading to serious complications. In the brain, inflammation can lead to neuron damage, and in the lungs inflammation can significantly lower the body’s ability to oxygenate blood. With its unique targeting abilities, Ashvattha’s hydroxyl dendrimer-based delivery system can bring medication directly to the immune cells causing harmful inflammation: macrophages. The company has initiated multiple programs using their drug delivery system to tackle hyperinflammation that causes the progression of diseases such as COVID-19, neovascular age-related macular degeneration (wet AMD), neuroinflammatory diseases such as ALS and Alzheimer’s disease, and immune oncology. The hope is that by targeting and delivering medication to the activated macrophages that cause this inflammation, these inflammatory diseases can be treated and their progression halted.
Ashvattha is in early stages of the IND approval process for dendrimers that address imaging, wet AMD and oncology. The company has successfully completed preclinical and Phase I trials using their delivery system to treat neuroinflammation. Their Phase II trial for treating ARDS, a type of respiratory failure induced by widespread inflammation in the lungs and known to cause a significant portion of COVID-19 deaths, is expected to be completed by the end of the year. Once this trial is completed, Ashvattha will have a proof of concept for the hydroxyl dendrimer delivery system’s human efficacy which can help with advancement of the systems for neurodegeneration, macular degeneration and tumors.
Disease Areas with Chronic Inflammation:
Infectious disease/inflammation ✓
Oncology ✓
Ophthalmology (AMD) ✓
Neurology (Alzheimer’s, ALS, HD) ✓
Rheumatology (Arthritis) ✓
Cardiology (HF)
Pulmonology (COPD) ✓
Metabolic (Diabetes)
Gastrointestinal (IBD)
Hepatology ✓
Renal (renal failure) ✓
✓ = preclinical validation of targeting
Upcoming Work
FDA approval process
Meet the team
Ashvattha was founded by leaders in the scientific community with over twenty years of research experience on nanoscience and dendrimer technology as well as entrepreneurs with a strong track record with biotech startups. The founders have raised capital (over $1 billion) through IPOs and have taken several therapeutics from discovery to commercial launch.
Founder, Chief Medical Officer & Board Member
Sujatha Kannan, MD
MBBS, Jawaharlal Institute of Postgraduate Medical Education and Research
Founder & Chief Technology Officer
Kannan Rangaramanujam, PhD
CEO & President Board Member
Jeff Cleland, PhD
Founder, Chairman
Chief Business Officer
Matthew Brewer, MBA
Advisor
Board Member
Barbara Slusher, PhD
B.S. Dickinson College; M.A.S. JHU; PhD JHU
Market Opportunity
Ashvattha’s research has vast potential. If the dendrimer delivery system succeeds in clinical trials it could reach the global therapeutic market for cancer, autoimmune diseases, inflammation and neurodegenerative diseases. This is a total global market of $1 trillion which could potentially expand as Ashvattha’s products prove to be effective in treating these diseases.
Partnerships
With their drug delivery system still in development, Ashvattha has not formally entered into partnerships nor commercially distributed their therapeutics. That being said, Ashvattha is making progress on their life science partnerships with Pfizer and Eli Lilly. The company is in discussion with both Pfizer and Eli Lilly on piloting Ashvattha’s technology for treating neuroinflammatory diseases but are awaiting the results of Phase II trials.
In the future, Ashvattha could also partner with pharmaceutical companies that own the rights to shelved drugs that could become significantly more functional when paired with the dendrimer delivery system. For example, off-target toxicity from small-molecule drugs can cause dangerous side effects and is a major cause of clinical trial failure. Ashvattha’s hydroxyl dendrimer’s unique targeting capabilities can circumvent issues with off-target toxicity.
Social Impact
Ashvattha could potentially provide therapeutic solutions to some of the most serious and destructive diseases and abnormalities, freeing individuals from immeasurable amounts of struggle. There is consequently no doubt that if Ashvattha’s technology is shown to be effective on humans, it is a big win for society. Additionally, dendrimers are not only inexpensive to produce but also reduce the amount of medicine needed to treat a certain ailment. In turn, this means that Ashvattha’s therapies could end up both being more effective and costing less than traditional medications.
Company Structure
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